NOTTINGHAM, UK, ENCINITAS, CA; September 10, 2024 – VS-041, a novel and potentially life-saving treatment for heart failure, developed by Vasa Therapeutics, a San Diego-based biotechnology company, has reached a major clinical milestone with the first human subjects dosed at Quotient Sciences’ Nottingham, UK clinic.

In this phase, Quotient Sciences’ Translational Pharmaceutics® platform was selected to accelerate the drug into first-in-human (FIH) trials. Quotient Sciences’ on-demand manufacture of an immediate release (IR) tablet allowed for dosing and generation of clinical data in a shortened time.

The clinical program and recruitment of healthy volunteers to take part in the Nottingham, UK-based Phase I trial was also performed by Quotient Sciences. 

Heart failure and HFpEF: Addressing a global health challenge

VS-041 is in development as the first personalized medicine-based treatment of HFpEF. 

Heart failure is a major global health malady affecting 64 million people worldwide, placing a huge economic and social burden on health systems costing an estimated $108 billion per annum. 

Heart failure with preserved ejection fraction (HFpEF), or diastolic heart failure, is a life-threatening form of heart failure where the heart cannot properly fill with blood because the left ventricle has stiffened over time and cannot relax. It is estimated that more than half of heart failure patients develop HFpEF.

VS-041 has shown a robust reduction of cardiac fibrosis in preclinical HFpEF models by inhibiting the release of signalling collagen fragments, such as endotrophin (PRO-C6), that mediate fibroinflammatory responses and are biomarkers of worse outcomes in HFpEF patients. These data have been accepted for presentation at the American Heart Association’s 2024 Scientific Sessions conference in November.

Accelerating drug development with Translational Pharmaceutics®

Quotient Sciences’ Translational Pharmaceutics® platform optimizes the drug development process by integrating formulation development, on-demand drug product manufacturing, and healthy volunteer clinical testing within a single organization.

Using Translational Pharmaceutics®, Quotient Sciences has incorporated flexibility to manufacture tablets for the VS-041 program within a dosing bracket, with upper and lower dose extremes included within the regulatory submission. Doses can be selected based on emerging clinical data from each study period of the single ascending dose, allowing for greater speed while minimizing API usage.

Dr. Vanessa Zaan, Executive Drug Development Consultant at Quotient Sciences, said, “In drug development, particularly for small and emerging biotech companies, we know that speed matters. We are working with Vasa Therapeutics to obtain first-in-human data as soon as possible, but never at the expense of poor-quality science.” 

Dr. Artur Plonowski, CEO and Co-Founder of Vasa Therapeutics added, “We are extremely satisfied to use Quotient Sciences’ Translational Pharmaceutics® platform that seamlessly integrates custom manufacturing, regulatory, and clinical functions, allowing us to carry out our FIH study of VS-041 in a time- and resource-efficient manner. We are very enthusiastic about the promise of VS-041 as the first personalized medicine-based treatment for HFpEF and are working diligently with Quotient Sciences to rapidly bring this option to HFpEF patients.” 

Now entering its 17th year, Translational Pharmaceutics® has accelerated more than 500 molecules through key development milestones for global pharma and biotech companies manufacturing small molecule therapeutics.

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognized as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023. For more information, visit quotientsciences.com.

Quotient Sciences media contact:
Rachael Heath
[email protected] 

About Vasa Therapeutics

Vasa is a privately held biopharmaceutical company developing therapeutics that target the pathophysiology of cardiovascular aging. In addition to VS-041, Vasa programs include a portfolio of long-acting apelin peptide analogues for treatment of obesity patients at risk for skeletal muscle loss or cardiovascular disease. The company is also developing a best-in-class inhibitor of CamKIId for heart failure and life-threatening arrhythmias. For more information, visit www.vasatherapeutics.com.

Vasa Therapeutics media contact:
[email protected]

References

1. Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart 
   failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 
   18;118(17):3272-3287. doi: 10.1093/cvr/cvac013. Erratum in: Cardiovasc Res. 2023 Jun 
   13;119(6):1453. PMID: 35150240.
2. Cook C, Cole G, Asaria P, Jabbour R, Francis DP. The annual global economic burden of heart 
   failure. Int J Cardiol. 2014 Feb 15;171(3):368-76. doi: 10.1016/j.ijcard.2013.12.028. Epub 
   2013 Dec 22. PMID: 24398230.

SOURCE: Quotient Sciences Global News

Developing an active pharmaceutical ingredient (API) involves balancing quality and speed during the transition from candidate selection to first-in-human (FIH) clinical trials. Creating a safe, cost-efficient, and regulatory-compliant API production method is crucial to avoid costly repeat activities or bridging studies later in the development process.  

Analytical techniques, including solid state analysis, are essential for understanding how changes in the synthetic process influence API properties, especially for small-molecule oral solid-dose drugs. In this article, we speak with Dr. Richard Castledine, Head of Drug Substance Operations, about some of the main considerations that drug developers and their partners face in drug substance API synthesis.  

What is an “API” in drug manufacturing?  

An Active Pharmaceutical Ingredient (API) is the substance which offers a therapeutic effect in a pharmaceutical product, and is responsible for the drug’s pharmacological activity within the body. It is combined with excipients which aid in the delivery of the API but do not themselves have any pharmacological activity.

What is process route design in API manufacturing? What challenges are typically encountered in process route design?  

Process route design involves finding and selecting a synthetic pathway to the API which has favorable characteristics for large scale current Good Manufacturing Practice (cGMP) production.  

Modification or redesign of the process is often required to prepare larger batch sizes and ensure that API can be produced in a compliant and efficient manner. The following factors should be considered early in the drug development process:

• Ensuring safety when working with hazardous materials  
• Identifying and developing control strategies for process and degradation impurities which may otherwise remain in the API
• Avoiding the use niche or expensive starting materials or reagents for API synthesis, which can result in supply chain difficulties and issues with cost-effective scale-up
• Reducing costs and improving sustainability by using synthetic routes that have a high atom economy and process mass intensity    

What factors must be considered in optimizing drug substance API?  

A targeted approach is best for obtaining insight into an APIs physical and chemical properties, as well as the potential limitations that may occur in the manufacturing phase. Factors which should be considered include:    

• Route scouting. An initial, desk-based screening of potential synthetic routes can highlight specific challenges or concerns in a proposed sequence, including raw material and waste considerations.  
• Feasibility assessment. Targeted work in the laboratory can quickly establish the viability of a given approach and identify any potential issues for scale-up.
• Robustness. Understanding of the edges of failure of any given reaction conditions.  
• Salt screen. If ionizable groups are present in the compound, developing novel salt forms can advantageously alter API properties, including solubility, crystallinity, and stability. Alternate salt forms may also give an intellectual property advantage.  
• Crystallization screen. Initial API isolation is often of amorphous or thermodynamically less stable polymorphic forms. Obtaining a stable crystalline form imparts several advantages in early development for purity and form consistency and can also lead to optimized isolation conditions.
• Solubility studies. Identifying the solubility of the API under varying conditions (e.g. pH, solvents, biorelevant media) is important to determine its developability classification system (DCS) score and impact on the drug’s clinical bioavailability. This information also informs the formulation strategy; if poor solubility is observed, for example, the API’s particle size may be modified or formulation technologies utilized to overcome solubility limitations.  
• Stability studies. Stability issues can significantly delay any drug development program. Conducting stability studies with early technical batches provides essential data on how the quality of an API varies with time and environmental factors (e.g. temperature and humidity).
• Impurity identification. Identifying, isolating, and characterizing impurities is advantageous during API development. Once identified, drug development teams can deduce the mechanism of their formation and optimize manufacturing processes accordingly. Additionally, insights into control strategies and purge points can be gained through this process.  

Deploying data-driven API development strategies early in a program can mitigate downstream development risks. It is therefore critical to choose a drug development partner with extensive expertise in developing and analyzing API. 

Many of the activities listed above can be completed in parallel with interim outputs used to steer overall development decisions. When combined in this way, a holistic approach to process development is employed, avoiding delays and costs while facilitating efficient API scale-up.  

The resurgence of interest in psychedelic compounds over the past decade has opened new avenues for treating mental health conditions such as depression and PTSD, as well as other CNS disorders. The evolving landscape of psychedelic drug development presents exciting opportunities and significant challenges, including crucial safety protocols, legal and regulatory requirements.  

As research and development in this rapidly evolving space continues, we recently hosted a webinar discussing the crucial steps drug developers must consider. Read key takeaways below. 

Exploring the evolving landscape and types of psychedelic compounds 

Psychedelics are a class of psychoactive substances known for their ability to alter perception, mood, and cognitive processes. The term "psychedelics" encompasses a variety of compounds. Each presents unique challenges in terms of synthesis, scale-up, and regulatory compliance.  

Three key compound classes that we have focused on at Quotient Sciences are: 

• Tryptamines: Often naturally occurring with increasing interest of the synthesis of non-natural derivatives and analogues. 
• Ketamine and its derivatives: Known for their dissociative anesthetic properties. In 2019, the FDA approved intranasal esketamine for treatment-resistant depression. 
• Cannabinoids: A broad class of compounds with numerous therapeutic applications. 

Recent studies have underscored the potential of psychedelics like psilocybin and ketamine derivatives in treating a range of conditions by targeting brain areas that current treatments do not. The interest is not entirely new: Research conducted as early as the 1950s and 1960s also recognized their potential for psychiatric disorders. However, the Controlled Substances Act of 1970 in the US effectively banned their use, restricting much of the ongoing research and requiring specific licenses for the handling and use of these materials.  

Now, with perspectives shifting, the medicinal applications of psychedelics are once again under the spotlight.  

Key things to consider in the safe handling of psychedelic compounds 

Despite their typically low acute toxicity, psychedelics can have pronounced effects even at very low doses. These risks include altered perception and impaired decision-making giving rise to the potential for accidents or injuries in the lab. It is important to have robust containment measures that minimize staff exposure, and follow appropriate local and regional guidelines to reduce legal and regulatory risks by: 

1. Adhering to stringent regulations and careful safety measures when handling controlled substances such as psychedelics in the lab
2. Having the proper licenses to handle controlled substances
3. Maintaining strict security protocols for both production and storage 

These factors are essential to ensure the safety of employees, prevent cross-contamination within the facility, and reduce business risks. However, for many small pharmaceutical companies, the costs of establishing and maintaining the necessary capabilities and facilities to handle controlled substances can be prohibitively high. Building in-house expertise involves not only significant financial investment but also the need for specialized knowledge, rigorous training, and strict compliance with regulatory requirements. 

Overcoming the challenges of scale-up of psychedelic compounds 

Transitioning to the challenges of scaling up production of psychedelic compounds companies can face additional hurdles. For instance, the manufacture of these compounds on scale often requires the use of highly reactive and sometimes pyrophoric substances. Expertise in handling such substances is paramount, which means meticulous safety protocols and rigorous quality control measures must be applied at every stage. These challenges must be overcome while maintaining the additional controls and working practices associated with the containment of psychedelic compounds.  

Addressing the 14C drug substance synthesis of psychedelic compounds 

Like all potential drugs psychedelic compounds often have complex interactions within the body. The synthesis of 14C-labeled psychoactive compounds therefore enables the study of how these drugs are metabolized and distributed, providing essential details about their pharmacokinetic profile.  

The design of a radiolabeled synthesis also revolves around crucial considerations such as strategically placing the radioactive label within the center of molecule to avoid the potential for rapid metabolic cleavage if the label is placed, for instance on a side chain. 14C radiolabels are introduced from suitable building blocks like CO2 or NaCN which often requires a new synthetic approach to be developed to the target compound. The preparation of 14C labelled compounds requires specialized expertise in radiochemistry and stringent safety protocols to handle radioactive materials effectively. Balancing these factors is essential not only for scientific accuracy and safety but also for meeting regulatory requirements. 

Choosing a CDMO for psychedelics drug development  

Handling controlled substances such as psychedelics involves navigating stringent regulatory requirements, which present significant challenges for drug developers. Companies must secure licenses for handling controlled substances and adhere to strict security measures during production and storage.  

To overcome these challenges, partnering with a specialized contract development manufacturing organization (CDMO) capable of providing comprehensive support at every critical step can prove to be a cost-effective solution, ensuring compliance and efficiency while accelerating project timelines.

To learn more about these critical considerations and gain insights into navigating the challenges of psychedelic drug development, check out our recent webinar. 

A two-part interview with Martin Wing-King, Vice President and General Manager, Site Head at Quotient Sciences – Reading

Martin Wing-King, Vice President and General Manager, Site Head at Quotient Sciences—Reading, discusses the capabilities offered on-site at Reading and expertise that our team offers in formulation development for both simple and complex dosage forms. 

In this second part of our two-part blog feature on our Reading, UK site, Martin discusses Quotient Sciences’ approach to formulation development, explains how our experts approach “simple” and “complex” drug programs and choosing the most appropriate dosage form, and tailored solutions to meet the needs of pediatrics and rare disease drug programs.

Miss the first part of our series? Read it here.

Can you discuss Quotient Sciences’ approach when it comes to “simple” versus “complex” formulation development? 

Over the years, we’ve become known for our expertise in “complicated” formulation development. In that context, we commonly consider programs requiring modified release, hot melt extrusion, and other solubility enhancement techniques as more complex. The Reading facility has 12 GMP manufacturing suites. With the space, equipment, and expertise that we have in Reading, we can develop tablets, solutions, suspensions, and inhaled dosage forms as part of our formulation development capabilities—all depending on what the customer needs to meet the solubility, bioavailability, and other criteria needed for their drug.  

At the same time, we know that complex formulations are not always necessary to get into the clinic if the customer’s goal is simply to accelerate to FIH trials. The extra equipment that we recently brought online at Reading gives us capacity and tools to investigate simple formulations faster.  

For example, “drug in capsule” (DIC) and “powder in bottle” (PIB) approaches give our customers the opportunity to get their drug product into the clinic quickly for a Phase I trial. In these cases, we would use the Xcelodose® machine for directly filling API into capsules with a high level of accuracy and fill quantities between 0.1 and 100mg.  

These simple formulations are a great choice compared to alternative choices of hand filling or developing powder blend formulations. These approaches reduce analytical method development and manufacturing time, simplify stability requirements, and reduce API usage in Phase I studies—this also translates to savings, as the API can be conserved and used for later trials, or smaller batches can be made potentially of the API in the first place.  

How is this increased demand and scalability helping to meet pediatric and rare disease indication needs? 

 Rare and orphan diseases often have a much smaller patient population and can be overlooked due to their commercial viability, low volume requirements, or complex patient needs. We’re proud to say that these are areas are where we are well suited, with both expertise and equipment available to take on these smaller batches and novel use cases for our customers.  

Additionally, API for rare disease indications can be expensive or complicated to produce. It may even be in short supply. Conserving API is something we keep in mind for our customers’ programs. We have seen numerous times where a simple “drug in capsule” approach for Phase I and even Phase II trials saves and cost in developing more complex formulations, especially for pediatrics and rare disease use cases. 

Finally, are there any examples of programs where Reading has worked with other locations in Quotient Sciences’ network? Is there one that stands out for you? 

There have been several due to the nature of how we work as a business. We’ve done drug product manufacturing often in Reading to supply a clinical pharmacology program, such as a drug-drug interaction (DDI) study. Probably the best case is also where we conduct a Translational Pharmaceutics® program at our Nottingham Phase I clinic with healthy volunteers, as well. 

Another example that comes to mind is an oncology customer who partnered with us for formulation development and manufacturing of their drug product, a potential treatment for liver cancer. In this case, the API supply was limited and at a very high cost per kilogram. Not only that, but there were long lead times for new batches of the API and a multiyear Phase Ib/IIa trial was being conducted in multiple countries and had to be dosed in oncology patients. Recruitment rates were likely to vary from clinic to clinic.

We overcame the API challenges by using a “drug in capsule” approach to conserve API and worked closely with the customer to manufacture batches to resupply clinics throughout dosing periods for their trial.  

Based on favorable clinical data, we are now formulating the drug product that can be used in Phase IIb and beyond. The redeveloped formulation will be manufactured throughout 2024 to support Phase IIb dosing and we are in discussion about how our Philadelphia site may be utilized to support a larger Phase II/III program, potentially leading to commercial batches as they get ready for regulatory approvals.  

In this article by Pharma Focus, Dr. Andrew Lewis, the Chief Scientific Officer at Quotient Sciences discusses the efficiency of oral peptides and their attractiveness as a drug candidate.

"Continued advancements in drug delivery technologies will be crucial for improving oral peptides’ bioavailability, convenience and efficacy"

The increased availability of oral peptides promising development opens new horizons in GLP-1 treatment for not only obesity and diabetes but to related conditions, such as chronic kidney disease and end-stage renal disease.

Continue reading the article on Pharma Focus

Credit:

Pharmafocus, Volume 26 Issue 7, September 2024, pages 22-23. © Samedan Ltd

The surge in demand for GLP-1 agonist therapies will boost the biotech sector, driving innovation and growth in the years to come. 

In the United States alone, it is projected that the number of GLP-1 users will hit 30 million by 2030, or approximately 9% of the U.S. population. ¹ This rise in demand reflects the growing global challenge of managing chronic metabolic conditions such as diabetes and obesity. The Centers for Disease Control and Prevention (CDC) estimates that the prevalence of obesity in the U.S. has grown from 30.5% in 1999–2000 to 41.9% in 2017–20202. On a global scale, obesity has more than tripled since 1975.3  

The need for more effective treatments that improve patient outcomes and adherence is growing. Ten GLP-1 agonist drugs, including semaglutide (RYBELSUS®, Ozempic® and Wegovy®) and tirzepatide (Mounjaro® and Zepbound®) have already received FDA approval for managing Type 2 diabetes and weight loss. In an increasingly competitive space, companies are looking for alternative and more patient-friendly methods to administer these therapies other than by subcutaneous (SC) injection.  

In this article, we explore the growth of GLP-1 agonists, what they are, how they work and their benefits, and how Quotient Sciences are helping companies tackle challenges in the development of these therapies, including oral formulations. For more insight, be sure to sign up for email news and updates from Quotient Sciences.

What are GLP-1 agonists and how do they work? 

GLP-1 (glucagon-like peptide-1) and GIP (gastric inhibitory peptide) are key incretin hormones involved in regulating glucose metabolism. Both are produced in the gastrointestinal tract in response to food intake, specifically glucose and fats. When a person consumes food, GLP-1 is released from the intestines into the bloodstream, where it performs several key functions. It signals the pancreas to produce insulin, which helps lower blood sugar levels, and simultaneously tells the liver to reduce glucagon secretion, a hormone that typically raises blood sugar levels. The incretin analogues mimic the action of the naturally occurring hormones, but have been designed to be more potent and longer circulating.

Another function of GLP-1 is its ability to slow gastric emptying. By delaying the passage of food from the stomach to the small intestine, GLP-1 ensures that glucose is released into the bloodstream more gradually, preventing sharp spikes in blood sugar levels. It is also known that GLP-1 has a direct effect on reducing appetite via receptors in the brain. 

Why are GLP-1 agonists beneficial and what conditions do GLP-1 agonists treat?  

In recent years, much attention has been placed on the use of GLP-1 agonists as a treatment for obesity. Research indicates that newer generations of GLP-1 agonists can achieve an average weight loss of 15–25%, significantly surpassing the efficacy of earlier treatments.4 As research in this area continues, the industry is seeing that GLP-1s can offer significant benefits for patients, beyond blood sugar control and weight loss.  

For example, large-scale cardiovascular outcome trials (CVOTs) have demonstrated that GLP-1 receptor agonists (GLP-1RAs) can significantly reduce the incidence of major adverse cardiovascular events, including heart attacks and strokes.5 These drugs have also shown recent potential in protecting kidney function, as evidenced by their ability to reduce albuminuria and slow the decline of the estimated glomerular filtration rate (eGFR), a critical indicator of kidney health.6 Despite their benefits, like all drugs, GLP-1 agonists are not without side effects, such as nausea and vomiting, which tend to subside over time.   

Are oral solid dose formulations the future of GLP-1 therapies?  

Typically, most approved peptide-based medicines are administered via injection, which may be a drawback for some patients. Maximizing systemic absorption and achieving therapeutic drug levels of a peptide following oral administration is a challenge for drug developers due to degradation in the digestive tract and low, and often variable, absorption. Addressing these problems is crucial as research progresses from preclinical to clinical stages.  

Following decades of research in both academia and industry, innovations in peptide chemistry and drug delivery are enabling more peptides to be optimized for oral administration, making it easier for patients to start and continue their treatment. In addition a number of small molecular weight compounds targeting the GLP-1 receptor are in development and the availability of oral alternatives is likely to significantly change the therapeutic landscape.

As the scope of GLP-1 agonists continues to expand, their therapeutic potential is evident, opening new avenues for pharma and biotech companies and their outsourcing partners to explore. In clinical trials, the effects of combining GLP-1 agonists with other compounds to act synergistically is being investigated, presenting an exciting opportunity for innovation, enhanced efficacy, and broadened therapeutic applications.  

At Quotient Sciences, we can help make this process smoother with our integrated clinical pharmacology programs. From early drug development to Phase I trials, we provide the insights and support you need to make critical decisions faster and more effectively. Our formulation development and oral drug delivery expertise including extensive oral peptide experience can help your company harness the full potential of your molecule.  

Learn more about our capabilities

• Explore capabilities in oral peptides
• Explore capabilities in modified release
• Explore capabilities in formulation development 

References:

https://www.jpmorgan.com/insights/global-research/current-events/obesity-drugs

https://www.ncbi.nlm.nih.gov/books/NBK551568/

https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/expert-answers/byetta/faq-20057955#:~:text=Doctors%20do%20know%20that%20GLP,longer%2C%20so%20you%20eat%20less.

https://www.health.harvard.edu/staying-healthy/glp-1-diabetes-and-weight-loss-drug-side-effects-ozempic-face-and-more 

Ozempic®, Wegovy®, and RYBELSUS® are registered trademarks of Novo Nordisk A/S.

Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company. 

Bethanne Lee is a Project Manager working with our Miami, FL and Philadelphia, PA facilities. 

In her role, she helps streamline the implementation of Translational Pharmaceutics® programs in the US. She shares more about her role with Quotient Sciences and day-to-day in this interview. 

“The business lives by its manifesto, which is another aspect I like about working at Quotient Sciences. Decision-making is built around this, our culture fosters this, and our efforts in innovations are piloted by this.”

-Bethanne Lee

What does a project manager do at Quotient Sciences?  

In my role as a project manager at Quotient Sciences, my responsibility is to ensure the successful delivery of projects within set timelines, budget, and quality standards. A crucial part of my role involves leading and coordinating project activities with both my project team and the customer’s team to ensure seamless collaboration.

Describe a typical day in project management at Quotient Sciences.

Any typical day in project management can include preparing for upcoming customer meetings, issuing minutes, finishing follow-up activities from previous customer meetings, and meeting internally to track important activities within the project team. As a project manager, we work internally to find de-risking measures for the program, resolutions to any unforeseen issues that have arrived, and making decisions to progress a customer’s program. From time to time, project managers also support writing change orders.

How has your career at Quotient Sciences progressed?  

The Philadelphia site was previously QS Pharma and was acquired by Quotient Sciences in 2017. At this time, I was a financial analyst working part-time and previously held full-time positions as a laboratory scientist and business development manager since 2004.  

In 2020, I applied for and accepted a full-time position as a client services associate. This role had a global reach where our department supported services across all of Quotient Sciences’ sites in the UK and US. This role enabled me to expand my knowledge from drug product development and manufacturing to other areas of pharmaceutical development such as clinical pharmacology, bioanalysis, 14C ADME studies, and drug substance synthesis and manufacturing.  

In 2022, a project management position opened at the Philadelphia site. With previous technical, sales, and key account experiences, I wanted to take this knowledge and apply it to successfully manage projects. I was eager to do so with a passion for customer and team interactions that foster a healthy teamwork environment.

What experience did you have before you started in your role?

I’ve been with Quotient Sciences since 2004, after graduating from the University of Delaware with a Bachelor of Science degree in Laboratory Science. Prior to Quotient Sciences’ acquisition of QS Pharma in 2017, I held roles as an analytical scientist, project coordinator, business development manager, and financial analyst.

Did you require any qualifications for the role you applied for?  

I joined Quotient Sciences after graduating with my Bachelor of Science degree. In later roles with the company, I went on to obtain a Master of Science degree in Biomedical Science & Engineering from Drexel University and an MBA from Wesley College. These qualifications, congruent with experience in pharmaceutical development from a contract development and manufacturing organization (CDMO) perspective over the course of many years, have been very beneficial for the project manager role.

What learning or qualifications have you gained in this role?

In a typical drug product CDMO setting, a project manager might manage early-stage programs (Phase I and II), late-stage programs (Phase III, registration, validation, commercial), or be able to see a project through the whole process. Here, I have had the opportunity to manage our Translational Pharmaceutics® programs, a platform that touches all stages and truly lives our manifesto: Molecule to Cure. Fast. 

What is unique about Translational Pharmaceutics® is the real-time, adaptive, clinical manufacturing at our Philadelphia site based on emerging clinical data between cohorts, regimens, or periods being conducted at our clinic in Miami. In this setting, we learn the clinical pharmacology aspects of clinical trials and partner very closely with our clinical team throughout the project to manufacture and release the clinical supply for each dosing.

What do you enjoy most about your role?

A project manager is involved in various aspects of the business, which is what I find most enjoyable. They have a broad understanding of the operations and procedures across different departments, which is crucial for the success of a project. Additionally, they have financial responsibilities and must possess or be able to develop a strong business acumen, including the ability to effectively communicate with different teams.  

What aspects do you find most challenging?  

During some aspects of a program, an important activity or milestone may rely on individuals or departments that are not aware of the objectives of the project. The importance of meeting the milestone is, therefore, not an accountable action. This is what I find most challenging. Sometimes this is anticipated, making it crucial to be a step ahead and work with those individuals or departments so they also understand the objectives that the team is working towards. Sometimes this is not anticipated, making timely and effective communication key in bringing everyone on board with the goals the team is putting their efforts toward.  

What’s the team like?  

The project management department is a wonderful group of colleagues at all different levels of our careers. While we don’t work together within our project teams, as a department we rely on each other for support, meet frequently as a group, and create an environment to share best practices and structure for continual improvement. The project teams I work with are simply outstanding. I could not ask for a better group of extremely smart, scientifically-sound, motivated, and accountable team members to work with. We all share similar passions for bringing molecules to cures. Fast.

What advice would you give to someone applying for a role in your team?  

Do you like being an integral part of developing treatments and cures for patients? Does the word communication spur thoughts of opportunity and teamwork? Is customer satisfaction just as rewarding to you as it is for them? If yes to these questions, you would thrive in the project management team at Quotient Sciences.

What do you like most about working at Quotient Sciences?  

As a project manager, you start to build your team camaraderie and effectiveness by ensuring all members understand the project's purpose, objectives, and expectations. We have a great teamwork environment where we all hold each other accountable through support and motivation.  

The business lives by its manifesto, which is another aspect I like about working at Quotient Sciences. Decision-making is built around this, our culture fosters this, and our efforts in innovations are piloted by this. It is a rewarding feeling after every day knowing that what was accomplished daily was achieved through a business structured in integration and adaptiveness, enabling our projects to run better and ultimately achieving our manifesto in the process.